03.15.23 -- Specializing In Complexity From Consulting To Submission

Designing a clinical trial database is a balancing act. Any clinical program has multiple stakeholders who have both short- and long-term goals to achieve. Download this infographic to better understand the key considerations that should be discussed prior to designing a clinical trial database, all of which can impact the efficiency of the clinical program.

A small biotech company engaged Veristat early in clinical development for help with a novel biologic being tested for the treatment of an ultra-rare and aggressive hematologic malignancy with no available effective therapies. Discover what happened when the team collaborated to present a strategy to regulatory authorities in this case study.

Listen as North American Regulatory Affairs Director Kevin Hennegan identifies some of the key components of a cell and gene therapy marketing application in the United States and European Union and outlines several of the most common pitfalls and gaps that he has encountered with sponsor applications.

Most complex studies are considered challenging but not impossible. Learn from a collective of experts as they share their takeaways from conducting a natural history study for a rare pediatric disease and how the experience helped to create future successful decentralized clinical trials.

To advance complex, rare, and advanced therapy treatments to the market, teams need to deliver integrated, flexible solutions. Gain insight into navigating the complex challenges of accelerating therapies through clinical development to regulatory approval and commercialization.